The global cell and gene therapy market is experiencing explosive growth. Key growth factors include rising chronic/genetic disease prevalence, advancements in gene editing (CRISPR) and viral vectors, increased R&D funding, and favorable regulatory approvals.
Chicago, Jan. 27, 2026 (GLOBE NEWSWIRE) — According to recent data from Astute Analytica, the global cell and gene therapy market was valued at US$ 36.5 billion in 2024 and is projected to hit the market valuation of US$ 183.1 billion by 2035 at a CAGR of 17.5% during the forecast period 2026–2035.
The robust expansion of the cell and gene therapy (CGT) market is deeply rooted in its vibrant and rapidly growing clinical trial landscape. Around the globe, an extraordinary number of studies are underway, underscoring a widespread commitment among researchers, biotech firms, and pharmaceutical companies to push the boundaries of innovation. This active trial environment forms the foundation upon which the market’s future growth is built, reflecting a dynamic ecosystem constantly exploring new therapeutic possibilities.
Request Sample PDF Copy: https://www.astuteanalytica.com/request-sample/cell-and-gene-therapy-market
Currently, there are more than 2,000 active CGT clinical trials running worldwide, a testament to the diversity and depth of the therapeutic pipeline. These trials span a broad range of indications and modalities, from gene therapies targeting rare genetic disorders to advanced cell therapies for cancer and autoimmune diseases. The sheer volume of ongoing research highlights how the pipeline is continuously refreshed with novel candidates, ensuring a steady stream of potential breakthrough treatments entering the development pipeline.
Rise of In Vivo Gene Editing: A Transformative Approach
In vivo gene editing represents a transformative breakthrough in genetic medicine, where therapeutic modifications to a patient’s DNA are performed directly within the body. This approach simplifies the logistics of treatment by eliminating the need to extract and manipulate cells externally, thereby streamlining the entire therapeutic process. Moreover, in vivo gene editing broadens the horizon for treating a wide array of genetic disorders that were previously difficult or impossible to address with traditional methods.
Significant advancements in this field are being driven by innovative companies pushing the boundaries of what is possible. For example, Intellia Therapeutics is advancing NTLA-2002, an in vivo CRISPR-based therapy targeting hereditary angioedema, which is entering late-stage clinical trials in 2025. Meanwhile, Editas Medicine demonstrated promising preclinical proof-of-concept for its own in vivo gene editing platform toward the end of 2024. These milestones reflect rapid progress toward realizing the potential of in vivo gene editing to treat genetic diseases effectively and safely.
Addressing Manufacturing Challenges Through Automation and Decentralization
The cell and gene therapy market is actively tackling the substantial logistical and cost challenges inherent in the conventional manufacturing paradigm by increasingly focusing on automation and decentralization. Currently, there are 38 cell and gene therapies approved by the U.S. Food and Drug Administration (FDA), many of which were developed using manual, labor-intensive processes that are difficult to scale efficiently. These legacy methods limit the ability to produce therapies at the speed and volume required to meet growing patient demand.
Looking ahead, the market is gravitating toward purpose-built, automated manufacturing systems designed to handle smaller, personalized batches with greater efficiency and precision. Automation reduces human error, improves reproducibility, and streamlines complex production steps, making it possible to scale advanced therapies without compromising quality. This shift enables manufacturers to tailor treatments to individual patients while maintaining cost-effectiveness, a crucial factor in the commercialization of personalized medicine.
Manufacturing Expansion Fuels Cell and Gene Therapy Growth
The rapid growth of the cell and gene therapy market is sparking an unprecedented expansion in manufacturing capabilities. As an increasing number of innovative therapies advance through clinical trials, the demand for specialized production facilities that comply with Good Manufacturing Practice (GMP) standards has become a critical priority. This surge reflects the need to support the complex and highly sensitive manufacturing processes unique to cell and gene therapies, which differ significantly from traditional pharmaceutical production.
Alongside the growth in manufacturing capacity, the Contract Development and Manufacturing Organization (CDMO) ecosystem is expanding rapidly to meet industry needs. CDMOs play a pivotal role by providing the specialized expertise, infrastructure, and flexible production capabilities required to scale up these advanced therapies. Their collaboration with biotech and pharmaceutical companies accelerates the path from clinical development to commercial manufacturing, addressing the technical challenges inherent in producing viral vectors and cell-based medicines.
This wave of growth has triggered significant investment in new infrastructure and state-of-the-art technologies tailored to the unique demands of cell and gene therapy manufacturing. Facilities are being designed to handle the delicate biological materials with precision and safety, integrating advanced automation, closed systems, and rigorous quality controls. These innovations are essential for managing the complexities of producing viral vectors and living cell products at scale while maintaining consistency and regulatory compliance.
In Vivo Delivery: Leading the Cell and Gene Therapy Market
In 2024, the in vivo delivery method captured the largest revenue share within the cell and gene therapy market, a testament to its superior efficiency and broad applicability. Unlike ex vivo approaches, in vivo delivery involves administering therapeutic agents directly into the patient’s body, allowing for more streamlined treatment processes. This method’s ability to bypass complex cell extraction and manipulation steps has made it highly attractive to developers and clinicians alike, accelerating its adoption across a variety of therapeutic areas.
A groundbreaking milestone in 2025 showcased the true potential of in vivo delivery with the successful development and administration of a bespoke CRISPR-based gene therapy to a patient within just six months. This rapid turnaround exemplifies the promise of personalized medicine, where treatments can be tailored to an individual’s unique genetic profile and delivered swiftly to address specific conditions. Such advancements not only highlight the technological progress in gene editing but also demonstrate how in vivo methods can revolutionize the speed and precision of therapeutic interventions.
The in vivo segment’s rapid growth is driven largely by its capability to deliver systemic treatments that target multiple organs throughout the body. This versatility makes it particularly valuable for addressing complex diseases that affect several tissues or systems simultaneously. By enabling therapies to reach a wider range of biological targets, in vivo delivery expands the scope and effectiveness of gene therapy, offering hope for conditions previously considered difficult or impossible to treat.
North America’s Commanding Market Leadership
North America asserts a commanding presence in the drug delivery market, holding a dominant share exceeding 39.50%. This leadership reflects not only the region’s extensive healthcare infrastructure but also its vibrant and unmatched innovation ecosystem. The ability to consistently pioneer breakthroughs in drug delivery and advanced therapies has positioned North America as the global epicenter for cutting-edge medical advancements.
A critical driver of this market dominance is the proactive and supportive regulatory environment fostered by the U.S. Food and Drug Administration (FDA). In 2024, the FDA approved nine new cell and gene therapy products, signaling a strong commitment to facilitating rapid access to transformative treatments. This regulatory momentum encourages pharmaceutical and biotech companies to innovate aggressively, knowing that novel therapies have a clear pathway to market authorization.
The regulatory encouragement has helped cultivate an expansive research pipeline, with more than 2,500 active Investigational New Drug (IND) applications related to cell and gene therapies currently filed with the FDA. This robust pipeline reflects the tremendous scientific activity underway and the growing potential of these advanced therapies to redefine treatment paradigms. The sheer volume of INDs also underscores the market’s future growth prospects and the ongoing demand for sophisticated drug delivery technologies tailored to these novel modalities.
Top Companies in the Cell and Gene Therapy Market
- ALLOGENE THERAPEUTICS
- Amgen Inc.
- Astellas Pharma Inc.
- Atara Biotherapeutics, Inc.
- Bayer AG
- Biomarin
- Bluebird Bio, Inc.
- Bristol-Myers Squibb Company
- Celgene Corporation
- Cellectis
- Gilead Sciences, Inc.
- Hoffmann-La Roche Ltd
- ImmunoACT
- Johnson & Johnson
- Krystal Biotech, Inc
- Novartis AG
- Orchard Therapeutics plc
- Sana Biotechnology
- uniQure NV.
- Vericel Corporation
- Other Prominent Players
Market Segmentation Overview
By Therapy Type
- Cell Therapy
-
- Stem Cell Therapy
-
- T-Cells
-
- Dendritic Cells
-
- NK Cells
- Gene Therapy
-
- In-vivGene Therapy
-
- Ex-vivGene Therapy
-
- Gene Editing Therapies
-
- RNA-Based Therapies
-
- Others
By Indication / Therapeutic Area
- Oncology
- Solid Tumors
- Genetic Disorders
- Neurological Disorders
- Cardiovascular Diseases
- Ophthalmology
- Musculoskeletal / Orthopedic Disorders
- Infectious Diseases
- Metabolic Disorders
- Others
By Vector Type (Gene Delivery Method)
- Viral Vectors
-
- Adeno-Associated Virus (AAV)
-
- Lentivirus
-
- Retrovirus
-
- Herpes Simplex Virus (HSV)
-
- Adenovirus
-
- Others
- Non-Viral Vectors
-
- Lipid Nanoparticles (LNPs)
-
- Naked DNA/RNA Plasmids
-
- Electroporation
-
- Gene gun / microinjection
-
- CRISPR-Cas Delivery Systems (non-viral)
-
- Others
By Manufacturing Type
- In-house
- Contract Development & Manufacturing Organizations (CDMOs)
- Hybrid Models (e.g., early stage in-house, scale-up outsourced)
- Others
By End User
- Hospitals and Specialty Clinics
- Academic and Research Institutes
- Biopharma and Biotech Companies
- CDMOs and CROS
- Government/Public Health Bodies
- Others
By Region
- North America
- Europe
- Asia Pacific
- Middle East & Africa
- South America
For more information about this report visit: https://www.astuteanalytica.com/industry-report/cell-and-gene-therapy-market
About Astute Analytica
Astute Analytica is a global market research and advisory firm providing data-driven insights across industries such as technology, healthcare, chemicals, semiconductors, FMCG, and more. We publish multiple reports daily, equipping businesses with the intelligence they need to navigate market trends, emerging opportunities, competitive landscapes, and technological advancements.
With a team of experienced business analysts, economists, and industry experts, we deliver accurate, in-depth, and actionable research tailored to meet the strategic needs of our clients. At Astute Analytica, our clients come first, and we are committed to delivering cost-effective, high-value research solutions that drive success in an evolving marketplace.
Contact Us:
Astute Analytica
Phone: +1-888 429 6757 (US Toll Free); +91-0120- 4483891 (Rest of the World)
For Sales Enquiries: sales@astuteanalytica.com
Website: https://www.astuteanalytica.com/
Follow us on: LinkedIn | Twitter | YouTube
CONTACT: Contact Us: Astute Analytica Phone: +1-888 429 6757 (US Toll Free); +91-0120- 4483891 (Rest of the World) For Sales Enquiries: sales@astuteanalytica.com Website: https://www.astuteanalytica.com/
Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. IndiaShorts takes no editorial responsibility for the same.
